FASENRA - PFS To Pen Communication Downloadable PDF

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AstraZeneca is committed to supporting patients during

the CORONAVIRUS DISEASE 2019 (COVID-19) pandemic.


If you are concerned about your patients coming into the office to
receive their FASENRA® (benralizumab) injection during the COVID-19
pandemic and have made the determination that it is appropriate to
switch your patient(s) to the FASENRA Pen, below are a few important
steps you need to know.

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To begin, you need to submit a new prescription for FASENRA Pen. Access 360
can offer support through the complete referral process: simply submit the
Access 360 enrollment form, or submit the prescription directly to the patient’s
Specialty Pharmacy.
• Access 360 can provide assistance in performing a Benefit Investigation, including both Pharmacy
and Medical benefits, and will inform you/your office of any Prior Authorization requirements for your
patient(s) insurance
• The pharmacy that fulfills FASENRA Pen may not be the same pharmacy that fulfills FASENRA prefilled
syringe. Access 360 can also assist with triaging your referral to the appropriate network pharmacy

1 2 3
Once the Benefit Investigation is complete, you/your office will submit a Prior
Authorization to your patient’s insurance.
• Access 360 can provide Prior Authorization support
• CoverMyMeds is another option that you or your office may already be familiar with and comfortable using

2 3 Upon receiving insurance approval, the designated Specialty Pharmacy will contact
the patient directly to obtain consent and will ship FASENRA Pen directly to your
patient’s home. Patients/caregivers may inject after proper training in subcutaneous
injection technique, and after a healthcare professional determines it is appropriate.
• If you experience a delay in insurance approval, please contact Access 360 for more information
about this program

INDICATION IMPORTANT SAFETY INFORMATION


FASENRA is indicated for the add-on maintenance treatment of CONTRAINDICATIONS
patients with severe asthma aged 12 years and older, and with an Known hypersensitivity to benralizumab or excipients.
eosinophilic phenotype.
• FASENRA is not indicated for treatment of other eosinophilic conditions WARNINGS AND PRECAUTIONS
• FASENRA is not indicated for the relief of acute bronchospasm or Hypersensitivity Reactions
status asthmaticus Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash)
Please see additional Important Safety Information on next page have occurred after administration of FASENRA. These reactions generally
and full Prescribing Information, including Patient Information and occur within hours of administration, but in some instances have a delayed
Instructions for Use. onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

For any questions regarding the process of submitting a new FASENRA prescription
for your patient(s), please contact Access 360 for assistance at 1-833-360-HELP

1-833-360-HELP (1-833-360-4357) 1-833-FAX-A360 (1-833-329-2360) www.FasenraResources.com

Access360@AstraZeneca.com One MedImmune Way, Gaithersburg, MD 20878 US-39218 Last Updated 4/20
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to benralizumab or excipients.

WARNINGS AND PRECAUTIONS


Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur
within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating Disease
FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate,
should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic
withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before
initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue
FASENRA until infection resolves.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.
Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients
treated with placebo.

USE IN SPECIFIC POPULATIONS


A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit
www.mothertobaby.org/fasenra.
The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab
are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third
trimester of pregnancy.

INDICATION
FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
• FASENRA is not indicated for treatment of other eosinophilic conditions
• FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

PLEASE READ FULL PRESCRIBING INFORMATION, INCLUDING PATIENT INFORMATION.


You are encouraged to report negative side effects of AstraZeneca prescription drugs by calling 1-800-236-9933.
If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

FASENRA and FASENRA Pen are registered trademarks of the AstraZeneca group of companies.
©2020 AstraZeneca. All rights reserved.
US-39218 Last Updated 4/20

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